A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01051232
First received: January 14, 2010
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.


Condition Intervention Phase
Healthy
Drug: Active
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety; ECGs/vital signs [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: Yes ]
  • Safety; laboratory tests [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: Yes ]
  • Safety; physical examination/adverse event monitoring [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.
Placebo Comparator: Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.
Placebo Comparator: Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.

Detailed Description:

Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 20 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

  • A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
  • Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
  • Pregnant or nursing females; females of childbearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051232

Locations
Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01051232     History of Changes
Other Study ID Numbers: A8121035
Study First Received: January 14, 2010
Last Updated: April 22, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
filibuvir
pharmacokinetics
Japanese
Asian

ClinicalTrials.gov processed this record on August 28, 2014